5 INDICATIONS

Prolia® is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, See More

You are now leaving ProliaHCP.com. Please know that the sponsors of this site are not responsible for content on the site you are about to enter.

Please to continue.

Prolia® Mechanism of Action

Suggested Resources:

Helping your practice throughout the access and reimbursement process

Amgen® SupportPlus provides tools and resources to help your patients get Prolia®.

Insurance Verification Form

Insurance Verification Form

Initiate your patient’s benefit verification request for Prolia®

Amgen SupportPlus  video thumbnail

Amgen SupportPlus Insurance Verification Video

Watch this video to find out how to initiate your patient’s Amgen SupportPlus benefit verification for Prolia®

Co-pay Program Tearsheet

Co-pay Program Tearsheet

Get eligible commercial patients started with the Amgen SupportPlus Co-pay Program

Sample Letter of Medical Necessity

Sample Letter of Medical Necessity

Support your clinical rationale for treatment with Prolia®

Product Ordering Sheet

Product Ordering Sheet

Find helpful product information to use when ordering Prolia®

Treatment Referral Form

Treatment Referral Form

Refer your patient to an alternate site of care for administration of Prolia®

Prior Authorization Tip Sheet

Prior Authorization Tip Sheet

Find helpful information to consider when completing Prolia® PA requests

Amgen SupportPlus  video thumbnail

Prior Authorization Considerations Video

Watch this video to learn more about prior authorization considerations

Amgen® SupportPlus Insurance Verification Video

Call Amgen® SupportPlus at 1-866-264-2778 Monday - Friday 9:00 am – 8:00 pm ET.
Visit AmgenSupportPlus.com to learn how Amgen can help.

Insurance verification

Amgen Assist® can provide detailed information on insurance coverage, patient out-of-pocket costs, and prior authorization requirements.

Financial resources

Amgen Assist® can provide information about financial resources that may be available. For more information, contact Amgen Assist® at 1-866-AMG-ASST (1-866-264-2778).

Referrals to alternate sites of care

Search for alternate sites of care and pharmacies with Prolia Finder™ to help your patients get their Prolia® treatment.

Amgen® SupportPlus Insurance Verification Video

Call Amgen® SupportPlus at 1-866-264-2778 Monday - Friday 9:00 am – 8:00 pm ET.
Visit AmgenSupportPlus.com to learn how Amgen can help.


Icon location

Help patients locate a Prolia® treatment site

Search for alternate sites of care and pharmacies with Prolia Finder™ to help your patients get their Prolia® treatment.

Your Journey Towards Stronger Bones Discussion Guide

A resource to support your patient discussions about postmenopausal osteoporosis

​​

Download a 3D bone model to show patients the impact of untreated osteoporosis

Help patients understand why it is critical to actively strengthen bone through treatment and reduce their fracture risk.1

Final video USA-162-82655
Video Player is loading.
Current Time 0:00
Duration 3:25
Loaded: 4.84%
Stream Type LIVE
Remaining Time 3:25
 
1x
    • Chapters
    • descriptions off, selected
    • captions off, selected
    • en (Main), selected
    ​​

    Telemedicine Coding and Resources

    CMS Guidance on CPT and HCPCS Codes

    Medicare Telemedicine Healthcare Provider Fact Sheet

    green_link_arrow

    cms.gov

    AMA Guidance on Telemedicine Coding

    AMA Quick Guide to Telemedicine in Practice

    green_link_arrow

    ama-assn.org

    Important Notice: These links are to external third-party websites not affiliated in any way with Amgen. By using these links, you will leave our website. They are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Amgen of any of the products, services, or opinions of the organization or individual. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters, and appropriate coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. The information provided in this section should in no way be considered a guarantee of coverage or reimbursement for any product or service. Amgen bears no responsibility for the accuracy, legality, or content of the external site or for that of subsequent links.


    Helping your patients on Prolia® manage life with osteoporosis

    Bone Matters® logo

    Bone Matters® will provide support for your Prolia® patients and help encourage them to return for their next injection by providing:

    *Reminder communications to patients and/or offices are intended for the limited purpose of delivering courtesy reminder notifications for your patients' next injection of Prolia®. However, it is up to your office and your patient to ensure they obtain their next injection in a timely manner and in accordance with the Prolia® Prescribing Information.

    Simple Ways to Sign Up for Amgen Assist®

    Register online at AmgenAssistSupport.com or call 1-866-AMG-ASST (1-866-264-2778), Monday through Friday, 9:00 am to 8:00 pm ET.

    Visit AmgenAssistSupport.com


    More Online Resources to Explore

    Amgen® SupportPlus

    The Amgen SupportPlus Co-Pay Program can help eligible commercially insured patients lower their out-of-pocket prescription costs, including deductible, co-insurance, and co-payment*

    For Prolia®, pay as little as $25 out-of-pocket for each dose

    Can be applied to deductible, co-insurance, and co-payment*

    green_link_arrow

    amgensupportplus.com

    *Eligibility criteria and program maximums apply. See www.amgensupportplus.com/copay for full Terms and Conditions.

    Amgen® SupportPlus Customer Portal

    A tool for managing patient benefit verifications and more. Submit, store, and retrieve benefit verifications electronically.

    green_link_arrow

    MyAmgenPortal.com


    Prolia® Patient Site (US)

    Information about postmenopausal osteoporosis and treatment, and access to resources for patients who are US residents.

    green_link_arrow

    Prolia.com


    Prolia Finder (HCP US)

    Search for alternate sites of care and pharmacies with Prolia Finder to help your patients get their Prolia® treatment.

    green_link_arrow

    ProliaFinder.com


    Bone Matters®

    Help your Prolia® patients stay motivated and on treatment with Bone Matters®, their personalized support program.

    green_link_arrow

    Visit Prolia.com to Learn More

     

    Amgen PMO Portal

    Amgen is dedicated to keeping you up to date with the latest educational resources and providing support as a trusted partner in postmenopausal osteoporosis care. With the PMO Portal, you can learn from leading osteoporosis experts and access on-demand resources anytime, anywhere.

    IMPORTANT SAFETY INFORMATION

    SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE:

    Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating Prolia in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Prolia in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.

    Contraindications: Prolia® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia®. Prolia® is contraindicated in women who are pregnant and may cause fetal harm. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia®. Prolia® is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria.

    Severe Hypocalcemia and Mineral Metabolism Changes: Prolia can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia. Adequately supplement all patients with calcium and vitamin D.

    In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. treatment with other calcium lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after Prolia injection.

    Same Active Ingredient: Prolia® contains the same active ingredient (denosumab) found in XGEVA®. Patients receiving Prolia® should not receive XGEVA®.

    Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia®. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia®.

    Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving Prolia®. An oral exam should be performed by the prescriber prior to initiation of Prolia®. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g. chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders. Good oral hygiene practices should be maintained during treatment with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®.

    For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Prolia® should be considered based on individual benefit-risk assessment.

    Atypical Femoral Fractures: Atypical low-energy, or low trauma fractures of the shaft have been reported in patients receiving Prolia®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.

    During Prolia® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of Prolia® therapy should be considered, pending a risk/benefit assessment, on an individual basis.

    Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia® Treatment: Following discontinuation of Prolia® treatment, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia®. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia® discontinuation. Evaluate an individual’s benefit/risk before initiating treatment with Prolia®. If Prolia® treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.

    Serious Infections: In a clinical trial (N = 7808), serious infections leading to hospitalization were reported more frequently in the Prolia® group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia®.

    Endocarditis was also reported more frequently in Prolia®-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.

    Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on Prolia®, prescribers should assess the need for continued Prolia® therapy.

    Dermatologic Adverse Reactions: Epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate with Prolia® compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing Prolia® if severe symptoms develop.

    Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia®. Consider discontinuing use if severe symptoms develop.

    Suppression of Bone Turnover: Prolia® resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.

    Adverse Reactions: The most common adverse reactions (>5% and more common than placebo) are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Pancreatitis has been reported with Prolia®.

    The overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia® group. A causal relationship to drug exposure has not been established. Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

    Indication: Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures.

    Please see Prolia® full Prescribing Information, including Medication Guide.

    IMPORTANT SAFETY INFORMATION
    SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE: Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating
    Back to Top

    Reference: 1. Prolia® (denosumab) prescribing information, Amgen.